2025 US Interchange Call for Abstracts - CDISC Abstracts

Instructions

 

Please use the form below to submit your abstract for consideration. PLEASE MAKE SURE TO PRESS THE SUBMIT BUTTON AT THE BOTTOM OF THE FORM. You should see a confirmation page after successful submission.

 

2025 US Interchange Abstract Topics - CDISC Topics

Abstracts Due: Friday, 25 April 2025

 

We welcome abstracts for the 2025 US Interchange on any of the CDISC topics listed below.

Note: CDISC is looking to expand understanding on how leveraging CDISC solutions and principles helps organizations adopt solutions that deliver improved real-world outcomes. Solutions can include people, process and technological changes through the application of CDISC standards and tools. Abstracts should focus on practical or applied experience in how CDISC standards, tools, and technologies have impacted your work in relationship to the topics below.

 

CDISC 360i End-to-End Adoption

  • Biomedical concepts, analysis concepts and extensions
  • Automation of data flow - demonstration of end-to-end flow and automated transformations

Digital Design

  • Digital Data Flow (DDF) adoption: digital protocol creation, ICH M11, the USDM standard and automated study builds
  • Integrating the DDF with upstream and downstream processes: examining challenges, benefits, and potential extensions
  • The influence of the DDF on drug development

Innovation in Clinical Trials and CDISC Standards

  • Decentralized Trials (DCT), including Digital Endpoints, Master Protocols, Patient and Rare Disease Registries
  • Automation
  • Artificial Intelligence (AI)
  • Accessing the Standards Library
  • Implementation of MDR

New Data Sources

  • Real World Data (RWD) / Real World Evidence (RWE), OMOP Data Model, HL7 FHIR, etc.
  • Electronic Health Records (EHR)
  • Digital Health Technologies (DHT)

Open Source Usage, Including CORE, OAK, COSMoS

  • CDISC Open Rules Adoption
  • Validation Tools: SEND, SDTM, ADaM, Define-XML etc.
  • Experience utilizing Open Source tools

Analysis Results Standards - ARS

  • From theory to practice - implementation challenges
  • Automation
  • Supportive software and formats
  • Experiences from volunteers and contributors

CDISC in Academic Research

  • Use cases describing the use of CDISC standards in academic research and challenges for academia
  • Use of CDISC standards in Healthcare Data Systems
  • Non-standard implementation of CDISC standards
  • Use of CDISC standards for data harmonization to facilitate data sharing and data reuse

Global Regulatory Submissions

  • Submission experience to FDA/PMDA/NMPA and other global health authorities
  • Experience and adherence to FDA division guidance vs CDISC standards
  • Experience integrating data from multiple studies in support of Integrated Summary of Safety (ISS) and Integrated Summary of Effectiveness (ISE)

CDISC Foundational Standards

  • CDASH/IG
  • SDTM/IG
  • ADaM/IG
  • SEND/IG
  • Define-XML

OTHER CDISC STANDARDS TOPICS

You are welcome to submit an abstract on any CDISC model experience, its implementation and associated planning. Related use cases are encouraged. We want to hear your success stories even if they do not fit into the topic areas mentioned.  CDISC is an open and multidisciplinary standard which interface with many areas and we are eager to hear about your experiences working with standards.

Contact Information
Abstract Submission
General Topic

Upload paper (not required).

After uploading, you MUST also hit the "Submit" button at the bottom of the form to submit your abstract.

One file only.
30 MB limit.
Allowed types: pdf, doc, docx.
Submission Guidelines:
  1. All author(s) approve submitting this work for presentation.
  2. The author(s) agree(s) to materially confine their presentations to information in the abstract if accepted for presentation.
  3. I acknowledge that if I am unable to present and fail to notify the planners and my session chair in a timely fashion, this may affect my ability to present at future CDISC Interchanges.
  4. Submission of the contact details provided are those of the presenter of the abstract. The primary author will be notified about the status of the abstract and is responsible for informing the other authors about the status of the abstract.
  5. That abstract author(s) agree(s) to avoid commercial content and refrain from overt selling of a product or service during their presentations.
  6. Submission of the abstract constitutes consent of all authors that CDISC will make presentation(s) and paper(s) available online, whether in video or PDF format, to the conference attendees, and after six (6) months, to the CDISC member community.
  7. If, after confirming their participation in the Interchange, the author(s) are unable to present due to extenuating circumstances, the author(s) should first attempt to determine and notify their session chair and planners of an appropriate replacement.

WE LOOK FORWARD TO RECEIVING YOUR CONTRIBUTION!

Questions?

If you have any questions on the suitability of an abstract or about the submission process, please contact CDISC at events@cdisc.org.

I confirm that I am submitting this abstract as CDISC content for the US Interchange.